Safety Study of PRTX-100 With Methotrexate or Leflunomide to Treat Active Rheumatoid Arthritis

Arthritis, Rheumatoid Clinical Trial

— SPARTA  

Official title:

A Phase Ib Randomized, Double-Blind, Placebo-Controlled, Multiple Dose, Dose Escalation, Safety and Tolerability Study of PRTX-100 in Combination With Methotrexate or Leflunomide in Patients With Active Rheumatoid Arthritis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01749787
• Other study ID #: PRTX-100-104
• Status: Completed
• Phase: Phase 1
• First received: December 6, 2012
• Last updated: December 18, 2014
• Start date: November 2012
• Est. completion date: August 2014

Study information

• Verified date: December 2014
• Source: Protalex, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationSouth Africa: Medicines Control Council
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine the safety and tolerability of PRTX-100 when various doses are given 5 times at weekly intervals to patients with active rheumatoid arthritis that are taking methotrexate or leflunomide. The drug is administered in a physician's office via an intravenous infusion. PRTX-100 may be effective in rheumatoid arthritis by suppressing the immune responses.

PRTX-100 is a highly-purified bacterial protein called Staphylococcal Protein A. In this study, cohorts of patients with active RA will receive sequentially higher doses of PRTX-100. There will be an inactive placebo cohort for comparison. Patients who do not attain low RA disease activity, by a commonly used measure, will leave the study at 3 months after their first dose of study drug.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: August 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Active RA with disease duration of not less than 6 months

• Concomitant stable methotrexate or leflunomide therapy

Exclusion Criteria:

• Diagnosis of any other inflammatory arthritis

• ACR Functional Classification of IV

• Significant systemic involvement secondary to RA (except for secondary Sjogren's syndrome)

• History of clincally significant hypogammaglobulinemia, common variable immunodeficiency, or humeral immunodeficientncy

• History of active tuberculosis, pro-thrombotic disorder, venous thrombosis requiring anti-coagulation, substance abuse, or serious psychiatric condition

• History of allergy or hypersensitivity to aspirin or non-steroidal cyclooxygenase inhibitors, Staphylococcal protein A

• History or presence of malignancy (except for surgically treated basal or squamous cell carcinoma of the skin at least 3 months prior to the start of study medication)

• Uncontrolled diabetes or Type 1 diabetes

• Unstable ischemic heart disease

• Serious active or recurrent infection, hepatic cirrhosis, or other medically unstable condition

• Systemic autoimmune diseases other than RA (such as systemic lupus erythematosus, scleroderma, inflammatory bowel disease, inflammatory myopathy)

• Positive for HIV, hepatitis B surface antigen, or hepatitis C antibody

• Pregnant or nursing females

• Inadequate hepatic, renal, or hematologic function

• Receipt of live vaccine within 5 weeks of start of study medication

• Concomitant administration of other biologic or non-biologic DMARDS, corticosteroids, or anti-CD20 antibodies

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid

Intervention

Drug:
• PRTX-100 at 1.5 mcg/kg

• PRTX-100 at 3.0 mcg/kg

• PRTX-100 at 6.0 mcg/kg

• PRTX-100 at 12.0 mcg/kg

• PRTX-100 at 240 mcg

• Placebo
Placebo administered via infusion once per week for 5 weeks
• PRTX-100 at 420 mcg

Locations

Country	Name	City	State
United States	Protalex Investigational Site	Albuquerque	New Mexico
United States	Protalex Investigational Site	Allen	Texas
United States	Protalex Investigational Site	Anderson	Indiana
United States	Protalex Investigational Site	Coeur d'Alene	Idaho
United States	Protalex Investigational Site	Duncansville	Pennsylvania
United States	Protalex Investigative Site	Los Angeles	California
United States	Protalex Investigational Site	Salisbury	North Carolina
United States	Protalex Investigational Site	Sarasota	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Protalex, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse Events	Number, severity and attribution of relatedness of Adverse Events	Screening up to 53 Weeks	Yes
Primary	Vital Signs and Physical Examinations	Change from baseline in blood pressure, heart rate, body temperature, and physical examination parameters	Screening up to 25 Weeks	Yes
Primary	ECG	Change from baseline in heart rate, PR interval, QT/QTc interval and QRS duration	Screening, first dose, 5th dose, 9 weeks, and 25 weeks	Yes
Primary	Clinical Laboratory Testing	Change from baseline in blood chemistry, hematology, and urinalysis values	Screening up to 25 weeks	Yes
Secondary	Disease activity	Number and percentage of patients attaining an ACR20, ACR50 and ACR70 response at Week 13. Change from baseline in CDAI, RAPID 3, and DAS28-CRP scores.	Screening up to 53 weeks	No
Secondary	Immunogenicity	Proportion of patients sero-positive and/or with titers > 512 at Week 4 and Week 9, the correlation between anti-product antibody and product clearance, and association between anti-product antibodies and adverse events.	Prior to first dose, and at 4 weeks, 9 weeks, and 25 weeks	No
Secondary	Pharmacokinetics	Plasma Cmax, AUC0-n, clearance and Vd.	Prior to first dose up to 72 hours after last dose of PRTX-100	No